MAUDE Adverse Event Report: COOK INC NGAGE NITINOL STONE EXTRACTOR; FFL DISLODGER, STONE, BASKET, URETERAL, METAL

Catalog Number NGE-017115

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.Name and address: phone: (b)(6), name and address: postal code: (b)(6), occupation: (b)(6), pma/510k #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It is reported during an unspecified procedure using a ngage nitinol stone extractor, "the mechanism jammed".It is not known how the procedure was completed after this difficulty was experienced.The hospital confirmed the patient is covid-19 negative.No adverse effects to the patient have been reported as a result of this occurrence.Additional details regarding the patient and event have been requested.At this time, no additional information has been provided.

Event Description

Additional information received 01sep2020.As reported, the device was used for an endoscopic laser fragmentation of a left ureteral calculus and renewal of a previously placed stent.The device was tested prior to use while in an uncoiled position.The device was placed via 4 french ureteroscope and used with a laser.The procedure was successfully completed with another similar device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.H3: device evaluated by mfg = other (81) - device evaluation has begun; however, a conclusion is not yet available.This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary.It is reported during an endoscopic laser fragmentation of a left ureteral calculus and renewal of a previously placed stent using a ngage nitinol stone extractor, "the mechanism jammed".The device was tested prior to use while in an uncoiled position.The device was placed via 4 french ureteroscope and used with a laser.The procedure was successfully completed with another similar device.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation - evaluation.Reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection and functional test of the device were conducted during the investigation.One ngage nitinol stone extractor was returned for investigation with the handle and basket formation in the closed position.The male luer lock adapter was tight, and the collet knob was tight and secure.The polyethylene terephthalate tubing measured 3.8cm in length.A kink was noted in the basket sheath 34.5cm from the distal tip.The handle did not actuate the basket formation, and the basket formation could not be manually actuated or pushed or pulled out.The basket assembly was stuck inside the basket sheath.A document-based investigation evaluation was performed.No related non-conformances were found, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.There were no identified gaps in the device manufacturing instructions or quality controls procedures.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is packaged with instructions for use, which caution, ¿do not use excessive force to manipulate this device.Damage to the device may occur.¿.Based on the available information, cook has concluded that the most probable cause for this event could not be determined.The provided information stated the device was tested before use, which indicated that the device was functional before use.We will continue our monitoring of similar complaints and have notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: NGAGE NITINOL STONE EXTRACTOR
• Type of Device: FFL DISLODGER, STONE, BASKET, URETERAL, METAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10436179
• MDR Text Key: 205191393
• Report Number: 1820334-2020-01537
• Device Sequence Number: 1
• Product Code: FFL
• UDI-Device Identifier: 10827002482941
• UDI-Public: (01)10827002482941(17)230414(10)13131899
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2023
• Device Catalogue Number: NGE-017115
• Device Lot Number: 13131899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Date Manufacturer Received: 09/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1